Effectiveness of Vestibular Rehabilitation for Improving Health Status in Patients With Fibromyalgia

Fibromyalgia Clinical Trial

Official title:

Effectiveness of Vestibular Rehabilitation for Improving Health Status in Patients With Fibromyalgia. Randomized Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05300529
• Other study ID #: UjaFM
• Status: Completed
• Phase: N/A
• Start date: June 1, 2021
• Est. completion date: April 1, 2022

Study information

• Verified date: October 2022
• Source: University of Jaén
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to analyze the effectiveness of Vestibular Rehabilitation for improving balance and quality of life of patients with Fibromyalgia Syndrome (SFM). Recruited subjects will be randomly assigned to an experimental group or control group (placebo). The experimental group will receive a standard Vestibular Rehabilitation program focused on eye stabilization and Vestibulo-Ocular Reflex (VOR) gain with the aim of improving motor and sensory strategies, while the control group will carry out a conventional rehabilitation program that will not include sensory strategy training. The frequency of treatment for both groups will be twice/week, along with daily performing (2 times/day, 5 days/week) of exercises at home. The total duration will be 8 weeks. The outcome measure are: disease impact (FIQ), perceived vertigo (DHI), and confidence in balance (ABC), at pre-treatment, post-treatment, one month follow-up and three months follow-up.

Description:

Fibromyalgia Syndrome (SFM) affects approximately 0.5 - 5% of the global population with ambiguity in diagnosis, physiopathology uncertainty and complex treatment.

Recent studies have shown frequent episodes of postural instability in SFM patients. This balance affectation seems to correlate with disturbances of quality of life, pain, impact of the disease, daily life activities and increased risk of falls. However, there is still controversy over the exact mechanism that explains this nonspecific balance disorder. Despite this preliminary finding of a possible visual and vestibular disorder, there are not known studies justifying the alteration of vestibular functions present in Fibromyalgia. Also, the are not certainty that Vestibular Rehabilitation (VR) provides short- and medium-term benefits.

Derived from the deficiencies observed in the revised literature, we propose to analyze the effectiveness of a Vestibular Rehabilitation program improving the balance and quality of life of people with Fibromyalgia Syndrome (SFM).

Therefore, a randomized, simple blind, two-group parallel controlled clinical trial has been designed to assess the effectiveness of Vestibular Rehabilitation treatment focused on eye stabilization exercises.

Subjects will be recruited from the Jaén Fibromyalgia Association (AFIXA) and randomly assigned to an experimental group or control group (placebo). Subjects who are diagnosed with SFM and between 18 and 70 years of age will be selected.

The experimental group will receive a standard Vestibular Rehabilitation program focused on the stabilization of the eye and gain of the Vestibulo-Oculo Reflex (VOR), while in the control group a conventional rehabilitation program will be carried out without visual stimulation. The frequency of treatment for both groups will be twice/week, along with daily exercises at home (2 times/day). The total duration will be 8 weeks. Measurements will be made in pretreatment, aftertreatment and one month follow-up and three months follow-up.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: April 1, 2022
• Est. primary completion date: December 20, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Aged 18-70 years,

• Diagnostic for fibromyalgia as described by the 2016 American College of Rheumatology (ACR)

Exclusion Criteria:

• Cognitive impairment impacting ability to fill out the scales and questionnaires.

• Musculoskeletal surgical intervention in the preceding 6 months and/or acute traumatic pathology to the inferior limb(s).

• Musculoskeletal disease with deformity of the inferior limbs.

• Diagnosed with vestibular, visual and/or auditory pathology.

• Neurologic illness that could be the cause of a balance disorder.

Related Conditions & MeSH terms

• Fibromyalgia
• Myofascial Pain Syndromes
• Postural Balance
• Vestibular Disease
• Vestibular Diseases
• Vestibular Rehabilitation

Intervention

Other:
• Vestibular Rehabilitation Exercises
The Vestibular Rehabilitation program focuses on stabilizing the gaze and gaining the Vestibular Ocular Reflex (VOR). The general mechanisms of recovery from vestibular injuries are vestibular adaptation and replacement exercises, which are designed to improve gaze stability and the interaction between sight and the vestibular system during head movements. The exercises will be carried out progressively according to the tolerance of the patient, varying the stimulus in intensity and frequency.
• Conventional Rehabilitation exercises
The conventional rehabilitation program in which exercises are performed to improve joint range, flexibility, and gait. It will always be done with the eyes open, on a firm surface and will not include training in sensory strategies

Locations

Country	Name	City	State
Spain	University os Jaén	Jaén

Sponsors (1)

Lead Sponsor	Collaborator
University of Jaén

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Height (Anthropometrics Data)	Patient height measured in meters (m)	Baseline
Other	Weight (Anthropometrics Data)	Patient's body weight in kilograms (kg)	Baseline
Other	Body Mass Index (Anthropometrics Data)	Weight and height will be combined to report body mass index in kg/m^2	Baseline
Other	Demographics Data	Registration of information provided by the patient on sex, age, education level. occupation and civil status	Baseline
Primary	FIQ (Fibromyalgia Impact Questionnaire)	Evaluates the impact of fibromyalgia on the patient's quality of life.The total score of the FIQ is from 0 to 100. A higher score means a greater impact of the disease on the patient.	Baseline
Primary	FIQ (Fibromyalgia Impact Questionnaire)	Evaluates the impact of fibromyalgia on the patient's quality of life.The total score of the FIQ is from 0 to 100. A higher score means a greater impact of the disease on the patient.	at eight weeks
Primary	FIQ (Fibromyalgia Impact Questionnaire)	Evaluates the impact of fibromyalgia on the patient's quality of life.The total score of the FIQ is from 0 to 100. A higher score means a greater impact of the disease on the patient.	at twelve weeks
Primary	ABC-16 (Activities-specific Balance Confidence scale-16 items)	Evaluates the balance confidence in performing activities of daily living. The total score of the ABC-16 is from 0% to 100%, with higher values associated with higher balance confidence.	Baseline
Primary	ABC-16 (Activities-specific Balance Confidence scale-16 items)	Evaluates the balance confidence in performing activities of daily living. The total score of the ABC-16 is from 0% to 100%, with higher values associated with higher balance confidence.	at eight weeks
Primary	ABC-16 (Activities-specific Balance Confidence scale-16 items)	Evaluates the balance confidence in performing activities of daily living. The total score of the ABC-16 is from 0% to 100%, with higher values associated with higher balance confidence.	at twelve weeks
Primary	DHI (Dizziness Handicap Inventory)	Evaluates the level of disability related to the impact of dizziness on daily function and quality of life. The total score of the DHI is from 0 to100 points. A higher score indicates a greater degree of disability due to the vertiginous symptoms.	Baseline
Primary	DHI (Dizziness Handicap Inventory)	Evaluates the level of disability related to the impact of dizziness on daily function and quality of life. The total score of the DHI is from 0 to100 points. A higher score indicates a greater degree of disability due to the vertiginous symptoms.	at eight weeks
Primary	DHI (Dizziness Handicap Inventory)	Evaluates the level of disability related to the impact of dizziness on daily function and quality of life. The total score of the DHI is from 0 to100 points. A higher score indicates a greater degree of disability due to the vertiginous symptoms.	at twelve weeks.
Secondary	CSI (Central Sensitization Inventory)	Evaluates a wide range of somatic and emotional symptoms common to central sensitization syndromes (CSS). The total score of the CSI from 0 to 100. Higher scores indicate greater severity of symptoms.	Baseline
Secondary	CSI (Central Sensitization Inventory)	Evaluates a wide range of somatic and emotional symptoms common to central sensitization syndromes (CSS). The total score of the CSI from 0 to 100. Higher scores indicate greater severity of symptoms.	at eight weeks
Secondary	CSI (Central Sensitization Inventory)	Evaluates a wide range of somatic and emotional symptoms common to central sensitization syndromes (CSS). The total score of the CSI from 0 to 100. Higher scores indicate greater severity of symptoms.	at twelve weeks.
Secondary	PCS (Pain Catastrophizing Scale)	Evaluates the patient's catastrophic thoughts. The total score of the PCS from 0 to 52. Higher scores indicate a greater presence of catastrophic thoughts.	Baseline
Secondary	PCS (Pain Catastrophizing Scale)	Evaluates the patient's catastrophic thoughts. The total score of the PCS from 0 to 52. Higher scores indicate a greater presence of catastrophic thoughts.	at eight weeks
Secondary	PCS (Pain Catastrophizing Scale)	Evaluates the patient's catastrophic thoughts. The total score of the PCS from 0 to 52. Higher scores indicate a greater presence of catastrophic thoughts.	at twelve weeks.
Secondary	TSK (Tampa Scale for Kinesiophobia)	Evaluates fear of movement to injury. The total score of the TSK from 11 to 44 points. Higher scores indicate a greater fear of movement.	Baseline
Secondary	TSK (Tampa Scale for Kinesiophobia)	Evaluates fear of movement to injury. The total score of the TSK from 11 to 44 points. Higher scores indicate a greater fear of movement.	at eight weeks
Secondary	TSK (Tampa Scale for Kinesiophobia)	Evaluates fear of movement to injury. The total score of the TSK from 11 to 44 points. Higher scores indicate a greater fear of movement.	at twelve weeks.
Secondary	VAS-pain (Visual Analogue Scale)	Evaluates the pain on a numerical scale from 0 to 10. Higher scores indicate more pain	Baseline
Secondary	VAS-pain (Visual Analogue Scale)	Evaluates the pain on a numerical scale from 0 to 10. Higher scores indicate more pain	at eight weeks
Secondary	VAS-pain (Visual Analogue Scale)	Evaluates the pain on a numerical scale from 0 to 10. Higher scores indicate more pain	at twelve weeks
Secondary	SF-12 (12-Item Short Form Survey)	Evaluates the impact of health on an individual's everyday life. Used as a quality of life measure.	Baseline
Secondary	SF-12 (12-Item Short Form Survey)	Evaluates the impact of health on an individual's everyday life. Used as a quality of life measure.	at eight weeks
Secondary	SF-12 (12-Item Short Form Survey)	Evaluates the impact of health on an individual's everyday life. Used as a quality of life measure.	at twelve weeks
Secondary	FES-I (Falls Efficacy Scale-International)	Evaluates the fear of falling. The total score of the FES-I from 16 to 64 points. Higher scores indicate greater fear of falling.	Baseline
Secondary	FES-I (Falls Efficacy Scale-International)	Evaluates the fear of falling. The total score of the FES-I from 16 to 64 points. Higher scores indicate greater fear of falling.	at eight weeks
Secondary	FES-I (Falls Efficacy Scale-International)	Evaluates the fear of falling. The total score of the FES-I from 16 to 64 points. Higher scores indicate greater fear of falling.	at twelve weeks
Secondary	FSS (Fatigue Severity Scale)	Evaluates severity of fatigue. Higher scores indicate a greater severity of fatigue	Baseline
Secondary	FSS (Fatigue Severity Scale)	Evaluates severity of fatigue. Higher scores indicate a greater severity of fatigue	at eight weeks
Secondary	FSS (Fatigue Severity Scale)	Evaluates severity of fatigue. Higher scores indicate a greater severity of fatigue	at twelve weeks
Secondary	20-item JAEN screening tool	Evaluates balance and neuromotor function in patients with fibromyalgia. Thd total scale of the Jaen-Screening Tools, from 0 to 80 points. A higher score indicates a greater degree of balance disorder.	Baseline
Secondary	20-item JAEN screening tool	Evaluates balance and neuromotor function in patients with fibromyalgia. Thd total scale of the Jaen-Screening Tools, from 0 to 80 points. A higher score indicates a greater degree of balance disorder.	at eight weeks
Secondary	20-item JAEN screening tool	Evaluates balance and neuromotor function in patients with fibromyalgia. Thd total scale of the Jaen-Screening Tools, from 0 to 80 points. A higher score indicates a greater degree of balance disorder.	at twelve weeks
Secondary	SVV (Subjective Visual Vertical)	Evaluates the perception of verticality, measured using the Subjective Visual Vertical (SVV) test using a virtual reality device.	baseline
Secondary	SVV (Subjective Visual Vertical)	Evaluates the perception of verticality, measured using the Subjective Visual Vertical (SVV) test using a virtual reality device.	at eight weeks
Secondary	SVV (Subjective Visual Vertical)	Evaluates the perception of verticality, measured using the Subjective Visual Vertical (SVV) test using a virtual reality device.	at twelve weeks
Secondary	Stabilometric Platform	Instrument composed of resistive pressure sensors, used to measure the static or postural balance. The test was performed under both eyes-open and eyes-closed conditions.	Baseline
Secondary	Stabilometric Platform	Instrument composed of resistive pressure sensors, used to measure the static or postural balance. The test was performed under both eyes-open and eyes-closed conditions.	at eight weeks
Secondary	Stabilometric Platform	Instrument composed of resistive pressure sensors, used to measure the static or postural balance. The test was performed under both eyes-open and eyes-closed conditions.	at twelve weeks
Secondary	Therapeutic Adherence at home	It assesses adherence to home treatment through a weekly record diary, where patients must record the number of times a day they perform the prescribed exercises, with a range of 0 to 80. Higher scores indicate greater adherence to home treatment. A score of 80 indicates 100% adherence.	Throughout the intervention phase, eight weeks
Secondary	Satisfaction level	Evaluates the level of satisfaction using a Likert scale, with five response options, from "very dissatisfied" to "very satisfied". The total score of 0-24. A high score indicates greater satisfaction	at eight weeks
Secondary	GRC (Global Change Rating Scales)	Assesses whether the patient's health status has improved or deteriorated after the treatment received, with ten response options ranging from "the worst it could be" to "the best it could be"	at eight weeks